🔍 RecallPedia

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Class I - Dangerous
🏥 Medical Devices Recalled: July 10, 2019 Radiometer America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Radiometer America Inc
Reason for Recall:
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Product Codes/Lot Numbers:

All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2320-2019

Related Recalls

Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.

Radiometer America

Class I - Dangerous

From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.

Jul 2, 2018 Other Medical Devices Nationwide View Details →

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Radiometer America

Class I - Dangerous

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again

May 25, 2018 Other Medical Devices View Details →